Kornimate/medical-research-clean huggingface dataset:
robotic-assisted hysterectomy: single- vs. multi-port laparoscopic access

Conditions: Activity, Motor; Pain; Wound

Summary: robotic single site surgery (r-ssh) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. we, perform a randomized trial to compare r-ssh with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

the study is scheduled to start february 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. procedures are performed by an experienced two-surgeon team. patients are randomized to either conventional multiport hysterectomy (n=62) or r-ssh (n=62). eligibility criteria are the same as for study 1. patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and body image questionnaire. postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. a follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. interviews and diaries will include time of return to home and work, daily activities including sexuality the r-ssh is performed using da vinci, xi robotic system. one single port, diameter 2 cm is applied. applying an additional assistant port is defined conversion of procedure the laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each. socio-economical consequences of r-ssh versus conventional laparoscopic hysterectomy study details in preparation sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. to include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. all calculation are based on two-sided testing with alpha of 0.05.

Eligibility criteria:
inclusion criteria: * hysterectomy on benign indication, * american society of anesthetists group 1 or 2, * bmi less than 35 kg/m2 * uterine size less than 300 g estimated by ultrasound, using ferraris formula. exclusion criteria: * adhesions * prior extensive abdominal surgery * prior midline incision, * cutis laxa of abdomen surgery * endometriosis * more than 1 cesarean section * malignant disease

Keywords: return-to-work, visual analogue pain score, cosmesis
evaluation and control of wag in pacu within patient and caregiver breathing zone

Conditions: Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery

Summary: the purpose of this study is to evaluate anesthetic gas in the pacu within patient and caregiver breathing zones.

the purpose of this single-center, multi-arm, randomized controlled study is to evaluate use of the iso-gard mask in patients immediately following a surgical procedure in which inhaled anesthetic is used as the primary modality of anesthesia, for the following: 1) measure the waste anesthetic gas emanating from patient during the immediate one hour post-operative recovery period in the pacu; 2) measure waste anesthetic gas within pacu caregiver's breathing zone; and 3) determine the efficacy of the iso-gard mask in reducing caregiver's exposure to waste anesthetic gas in the pacu. subjects who will receive either sevoflurane or desflurane inhaled anesthetic will be enrolled in this study. subjects will be randomized to receive either the iso-gard scavenging mask or a traditional supplemental oxygen mask post operatively; all other elements of the subjects' care will be in accordance with the institution's standard of care.

Eligibility criteria:
inclusion criteria: * subject is 18-120 years of age. * patients requiring inhaled anesthetic agents as part of their anesthesia during surgery (sevoflurane or desflurane) * patients with following outpatient procedures scheduled for a duration of greater than 2 hours per the operating room schedule: 1. . bariatric procedures 2. robotic surgery cases 3. orthopedic 4. gynecological procedures 5. ent 6. plastic * not documented as terminally ill * subject expected to remain in pacu for at least one hour * subject or legally authorized representative has provided written informed consent prior to the procedure using a form that is approved by the institutional review board (irb). exclusion criteria: * patients are/were given/planned to be given total iv anesthetics during surgery * any patient that is not expected to tolerate a mask in pacu * subject has already been enrolled in study * subject is an employee of the investigator or has involvement in other studies under the direction of investigator or study site * women who are pregnant * end of anesthetic gas administration in pacu bay greater than 45 minutes

Keywords: waste anesthetic gas (wag)
cognition and hrqol in adults with highly-active rms in year 3 and 4 after initial mavenclad® dose (clarify ms extension)

Conditions: Multiple Sclerosis

Summary: the purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (rms). this was the extension study to clarify ms (nct03369665), to assess cognitive impairment and health related quality of life (hrqol) in participants with highly active rms, at 4 years after initial dose of mavenclad® tablets.


Eligibility criteria:
inclusion criteria: * have at least clarify ms baseline data on symbol digit modalities test (sdmt) * received at least a single dose of cladribine tablets in the clarify ms study * completed the final study visit (m24) of the clarify ms study * capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and this protocol exclusion criteria: * participant is considered by the investigator and sponsor, for any reason, to be an unsuitable candidate for the study * participation in other studies.

Keywords: multiple sclerosis health related quality of life mavenclad® relapsing multiple sclerosis cladribine cognitive impairment cognition fatigue
evaluation of the reproducibility inter-observer of the ultrasound anomalies of the salivary glands in sjogren's disease

Conditions: Sjogren's Disease

Summary: this aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands. the reproducibility is measure on patients and not on recorded data.


Eligibility criteria:
inclusion criteria: * men and women from 18 to 80 years old * patients recruited during the multidisciplinary consultation of sjogren's disease, filling the criteria of sjogren's disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands * the patients will have to be capable of adhering to the protocol of study and of having understood it. * the patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion exclusion criteria: * not cooperative patient and having refused to sign the informed consent. * patient incapable to understand the protocol, under guardianship or under guardianship. * unaffiliated patients to the social security.

Keywords: reproductibility
botulinum toxin for trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: trigeminal neuralgia (tn) is one of the most painful and common types of neuropathic pain encountered by clinicians. it is typically treated pharmacologically with anticonvulsants,but these can be ineffective, or can lose their effectiveness over time.botulinum toxin type a (bont-a) is an exotoxin released by the gram-positive, anaerobic bacillus clostridium botulinum that causes flaccid paralysis by blocking neurotransmitter release by axonal terminals. as a contaminant, it is the cause of potentially lethal botulism poisoning; however, as a drug, it has been widely used in the treatment of dystonia, as well as for non-surgical cosmetic treatment. more recently, studies investigating the ability of bont-a to treat pain have been increasing. in 2012, the investigators reported the results of a randomized, double-blind, and placebo-controlled trial in which subcutaneous injection of bont-a at the site of pain provided long-term effective relief in tn. the investigators noted that adverse effects were mild, as well. other studies on tn have estimated the effectiveness of bont-a treatment in tn to be 47-73%. however, bont-a treatment is still ineffective in more than 30% of patients.in this study, the investigators investigate whether different treatment methods have different efficacy and safety.


Eligibility criteria:
inclusion criteria: * age \>18 years * clinical diagnosis of classical trigeminal neuralgia according to the ichd iii (beta) * the pain involved the gingiva * signed informed consent prior to entering study exclusion criteria: * comorbid diseases that may be exacerbated by botulinum toxin type a (e.g., myasthenia gravis, motor neuron disease, or lambert-eaton syndrome). * receiving drugs with neuromuscular junction toxicity 1 week before botulinum toxin type a treatment (e.g. quinine, aminoglycosides or penicillamine) * had an infection of the skin or mucosa at any of the injection sites. * psychiatric illness. * malignancy. * pregnancy or lactation. * currently participating or previously participated in any investigational drug or device study within 6 months.
comparison of high flow oxygenation therapy and cpap in children with bronchiolitis.

Conditions: Respiratory Syncytial Virus Bronchiolitis

Summary: bronchiolitis in infants and young children often requires respiraty support. in denmark continous positive airway pressure ( cpap) are routinely used in children with moderate-severe bronchiolitis. the aim of the study is to compare cpap and high flow oxygenation therapy (hfot) as tools of respiratory support in infants and young children with bronchiolitis. infants and young children with moderate-severe bronchiolitis and are randomized to either cpap or hfot.


Eligibility criteria:
inclusion criteria: * infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision) exclusion criteria: * severe bronchiolitis with p c02 \> 9, decreased consciusness and risk for early progression to intensive therapy.

Keywords: continuous positive airway pressure high flow oxygenation therapy bronchiolitis children
the elisa study - evaluation of lixivaptan in subjects with autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: this is a phase 2, open-label, parallel-group, multiple dose study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan in autosomal dominant polycystic kidney disease subjects with chronic kidney disease (ckd) in stages ckd1, ckd2 or ckd3.

therapeutic interventions aimed at counterbalancing the effect of vasopressin and/or normalizing intracellular levels of camp may be effective in delaying disease progression in autosomal dominant polycystic kidney disease (adpkd). the primary objectives of this study in subjects with adpkd are: * to characterize the safety and tolerability of lixivaptan following multiple doses in adpkd subjects with relatively preserved kidney function (chronic kidney disease ckd1 and ckd2) and moderately impaired renal function (ckd3). the secondary objectives of this study are: * to characterize the pk profile of lixivaptan and its major metabolites following multiple doses of lixivaptan in adpkd subjects with relatively preserved kidney function (ckd1 and ckd2) and moderately impaired renal function (ckd3). * to characterize the pharmacodynamic effect of lixivaptan on urine output, urine osmolality, total kidney volume, serum vasopressin, and serum creatinine following multiple doses of lixivaptan in adpkd subjects with relatively preserved kidney function (ckd1 and ckd2) and moderately impaired renal function (ckd3).

Eligibility criteria:
inclusion criteria: * male or female, between 18 and 65 years of age at the time of screening * estimated glomerular filtration rate (egfr) ≥ 30 ml/min/1.73 m2 with egfr calculated by the ckd epi equation * diagnosed with adpkd by modified ravine criteria * considered by investigator to be in good health relative to underlying ckd status and clinically stable with respect to underlying ckd exclusion criteria: * known sensitivity or idiosyncratic reaction to lixivaptan, its related compounds such as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine), or any compound listed as being present in the study formulation * women who are pregnant or breast feeding * subjects have taken tolvaptan, oral or intravenous antibiotics, or any investigational drug or used an investigational device within 30 days or 5 half-lives, whichever is longer, prior to first study dose * subject has a transplanted kidney, or absence of a kidney * subjects with clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia) * subjects with clinically significant liver disease, or clinically significant liver function abnormalities or serology other than that expected for adpkd with cystic liver disease at baseline * subjects with any clinically significant concomitant disease or condition other than adpkd (including treatment for such conditions) that, in the opinion of the investigator, could either interfere with the study drug or pose an unacceptable risk to the subject
observational study of novonorm® in subjects with diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to review the safety and efficacy of novonorm® (repaglinide) in post-marketing use.


Eligibility criteria:
inclusion criteria: * type 2 diabetes
implementation of a diabetes management protocol as compared to conventional management in a heart hospital's non-intensive care unit: randomized clinical

Conditions: Diabetes Mellitus Type 2

Summary: to asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of ssi) in a hearth hospital's non-intensive care unit.

management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days. eligibility criteria: patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dl or random blood glucose greater 200 mg / dl in both sexes, aged greater 18 years.

Eligibility criteria:
inclusion criteria: * previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dl or random blood glucose greater 200 mg / dl in both sexes, age greater than or equal 18 years exclusion criteria: * patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study
this study performed to develop a new technique for measuring the intra abdominal pressure

Conditions: Abdominal Compartment Syndrome

Summary: the purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.

in this prospective study, 40 patients undergoing elective surgery were included. patients were divided into four groups of 10 patients. the control group (group c) was not subjected to laparoscopic intervention. laparoscopic surgery was respectively performed with an intra-abdominal pressure of 9, 12 and 15 mmhg in groups l (low), m (medium), and h (high pressure). intraocular pressure was measured binocularly in each patient at three different time (before, during and end of surgery) using a contact tonometer.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 30 kg/m2 or less * american society of anesthesiologists (asa) status i-ii exclusion criteria: * pre-existing eye disease, * cardiovascular or neuromuscular disease, * difficult intubation, * the use of any antihypertensive agents.

Keywords: intra-abdominal pressure, intraocular pressure, abdominal hypertension, laparoscopy, critical care
mr imaging of fat deposition in adolescents with first time antipsychotic use

Conditions: Adiposity

Summary: this study will focus on a population of antipsychotic (ap) naïve adolescents and young adults and will measure fat accumulation in relation to exposure to atypical antipsychotic medications.

atypical antipsychotics (aaps) are known to cause metabolic dysfunction, and adolescents are especially vulnerable to this effect. the anthropometric measures routinely used to monitor these metabolic side effects may, in fact, underestimate risk in the pediatric population as they are not a good index of hepatic and visceral adipose tissue. this study will measure fat accumulation over a 12 week period in adolescents and young adults taking an aap for the first time. mri imaging will measure hepatic, and visceral adipose tissue at baseline and study end. an oral glucose tolerance test will measure glucose resistance and insulin sensitivity. in an exploratory fashion, investigators will also image the brain to assess for volumetric changes which may occur in association with aap treatment and changes in metabolic indices.

Eligibility criteria:
inclusion criteria: * ap naïve or ap-free for 3 months or greater * prescribed an ap for treatment * age 12-35 * using contraceptive (females of child bearing age) exclusion criteria: * currently taking ap or been taking ap for greater than 1 week within the past 3 months * pregnant or planning to become pregnant * eating disorder (active or previous) * clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease * major medical or surgical event in the preceding 3 months * acute suicidal risk
a phase ib study of jmkx000197 injection in the treatment of malignant pleural effusion

Conditions: Malignant Pleural Effusions (Mpe)

Summary: a phase ib study to evaluate the safety, tolerance, pharmacokinetics, pharmacodynamics, and preliminary efficacy of jmkx000197 injection in the treatment of malignant pleural effusion


Eligibility criteria:
inclusion criteria: 1. the participant voluntarily joined the study, signed an informed consent form, and had good compliance. 2. age ≥ 18 years and ≤ 75 years old, regardless of gender. 3. participants with advanced solid tumors diagnosed by histopathology or cytopathology. 4. malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage. 5. eastern cooperative oncology group (ecog) performance status: 0 to 2. 6. life expectancy of at least 3 months. 7. adequate organ function. 8. female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of jmkx000197. the serum pregnancy test result should be negative 7 days before enrollment and must be a non-lactating participant. male participants must agree to use effective contraception during the study and for 6 months after discontinuation of jmkx000197. exclusion criteria: 1. bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion. 2. pleural effusion is either encapsulated or severely separated; or merge with chylothorax; or combined with infectious pleural effusion. 3. have used interferon gene stimulating factor (sting) agonists for pleural perfusion。 4. known allergies to the study drug or its excipient components. 5. have participated in other clinical trials within 28 days prior to randomization. 6. major surgery within 28 days prior to randomization. 7. central nervous system metastatic disease, leptomeningeal disease, or cord compression. 8. clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases. 9. uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to positive hbsag and hbv dna, positive hcv rna, positive hiv antibody test or combined infections within the first 28 days of randomization and require systemic anti-infective treatment. 10. have a history of organ transplantation. 11. any further condition which, in the opinion of the investigator, the participant is not suitable in the present study.
attention test and executive functions after stroke to predict depression.

Conditions: Post-stroke Depression

Summary: the purpose of this study is to determine whether cognitive function evaluation (sustained attention, executive functions, working memory) during acute post-stroke is predictive of a 3 months post-stroke depression.

1. baseline visit: after neurologic stability, 14 days or less after stroke and before discharge. 2. first assessment : 1. neurologic data: morphologic data (mri of the brain), stroke severity (nihsscore), aphasia assessment (boston diagnostic aphasia examination) if nihs verbal score ≥1, hemineglect assessment (bells test). 2. personal data assessment : i. socio demographic : age, gender, marital status, employment, level of education ii. medical history: medical treatments, psychiatric and non psychiatric history. c. psychiatric assessment i. mini international neuropsychiatric interview - depression ii. beck depression inventory iii. clinical global impression iv. standardized assessment of personality - abbreviated scale (sapas) v. fageström-c vi. alcohol use disorders identification test (audit-c) d. cognitive assessment: i. verbal memory : dubois's five words ii. clock drawing test iii. d2test (computerized) iv. verbal fluency (cardebat) v. working memory (digit span wais 3) vi. brixton (computerized) 3. assessment 3 months after the first assessment. phone call and psychiatric assessment: mini depression, beck depression inventory. barthel index and quality of life assessment.

Eligibility criteria:
inclusion criteria: * age 18 or more * ischemic or hemorragic stroke, diagnosed with radiology : cerebral ct or mri, 14 days or less after stroke * signed consent * social insurance regime affiliation exclusion criteria: * death * no possibility of follow-up * no french-speaker : insufficient command of french * deprivation of liberty : judicial or administrative decision * d2 test assessment impossibility * aphasia with major disorder of the understanding (boston \<8) * antidepressant treatment during stroke * depression during stroke * protected people

Keywords: depression